Remote VP, Regulatory Strategy & Due Diligence

Travere Therapeutics; Manchester (NH); On-site; USD 285,000 - 385,000; Full time

Benefits offered by this job

Premium health

Stock options

Performance bonus

Job summary

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for licensing, acquisitions, partnerships and external innovations. The role integrates regulatory strategy across clinical, nonclinical and CMC, assessing risk, guiding decision-making, and coordinating with executive leadership.

The ideal candidate has 15+ years in pharma/biotech with BD focus, strong GMP knowledge, and experience across biologics and small molecules.

Qualifications

• 15+ years in pharma/biotech with regulatory and business development focus, including clinical, manufacturing, and operations
• Experience leading due diligence in licensing, acquisitions, partnerships or external alliances
• Strong understanding of GMP requirements, regulatory expectations, and product lifecycle management
• Ability to translate complex regulatory findings into clear executive-level guidance and risk mitigation

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership and external opportunities.
• Assess regulatory development across all stages, including pediatrics and device considerations.
• Own integrated regulatory risk assessment and recommendations for each opportunity.
• Evaluate CMC aspects of drug substance/product development, control strategies, and lifecycle plans.
• Review CRO/CMO capabilities and readiness to support clinical and/or commercial supply.
• Coordinate with cross-functional stakeholders to prepare diligence reports and term sheets.
• Contribute to regulatory input in agreements, governance, and transition plans.
• Establish enterprise regulatory diligence standards, tools and risk frameworks.

Skills

Regulatory strategy

Due diligence leadership

Cross-functional collaboration

Executive communication

GMP knowledge

Biologics & small molecules

Education

Master's or PhD in pharmaceutical sciences or related field

Job description

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for licensing, acquisitions, partnerships and external innovations. The role integrates regulatory strategy across clinical, nonclinical and CMC, assessing risk, guiding decision-making, and coordinating with executive leadership.

The ideal candidate has 15+ years in pharma/biotech with BD focus, strong GMP knowledge, and experience across biologics and small molecules.